Morocco

Pharmacovigilance in Morocco is overseen by the Agence Marocaine du Médicament et des Produits de Santé (AMMPS) through its national vigilance and risk-management structures. AMMPS’s French-language Notification des effets indésirables page confirms national reporting channels for patients, healthcare professionals and companies involved in manufacturing, importing or distributing health products. The current Procédure d’octroi de l’AMM, Version 01 of April 2026, confirms the AMMPS marketing-authorisation framework and specifically states that its pharmacovigilance/risk-management division evaluates pharmacovigilance safety data and risk-management plans for relevant products. Morocco’s framework is evolving, and the currently accessible binding/public AMMPS material reviewed does not yet clearly publish, for every MAH, a universal numerical ICSR deadline, a mandatory Morocco-resident QPPV, a PSMF requirement, a fixed PSUR/PBRER frequency, or a routine pharmacovigilance-inspection cycle. These points should not be imported from EU GVP or from draft regulatory texts and presented as binding national requirements. MAHs should maintain effective post-market monitoring and comply with product-specific AMM conditions and current AMMPS instructions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.